34 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dario LC Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Walgreens
FDA UDI
WALGREEN CO.·00311917060897·Walgreens Covid+Flu A&B Antigen Test 2S
RESPIRONICS GOLOX
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 5, 2025
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 18, 2026
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 22, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 19, 2008
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 27, 2018
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·October 24, 2018
BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 30, 2018
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·October 11, 2018
BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·October 5, 2018
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·October 5, 2018
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·October 30, 2018
BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 14, 2019
BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 8, 2019
BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 13, 2018